FDA recall D-0262-2025

Aspen Biopharma Labs Pvt., Ltd. · Class II · drug

Product

Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.

Reason for recall

CGMP Deviations

Distribution

Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

Key facts

Status: Ongoing
Initiation date: 2025-02-07
Report date: 2025-03-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Medchal Malkajgiri, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0262-2025